The Food and Drug Administration (FDA) has announced that they are reviewing the safety of the implant Essure. The contraceptive device is manufactured by Bayer and has been on the market since 2002. The device is made of two metal coils which are inserted into the fallopian tubes as a way to block contraception.

However, the FDA says that they have received more than 5,000 complaints of medical issues, including abdominal pain, fatigue, headaches, and weight fluctuations, by female patients prescribed Essure since its approval. More than 400 women and/or their doctors have reported the coils moving away from the fallopian tubes and into other parts of the patient’s reproductive system.

There have also been reports of five fetal deaths, which occurred when the Essure device failed to prevent pregnancy.

Since its approval, the Essure device has been implanted into approximately 750,000 women. Based on the number of complaints the FDA has received, this means approximated one in every 150 women has had a problem with the device.

The FDA has scheduled a public hearing to be held on September 24, 2015 to review the safety of the product. The hearing will include the agency’s Obstetrics and Gynecology Devices Panel. This hearing is being scheduled due in part to a New York television news channel’s investigation regarding the inconsistencies which took place during the clinical trials of Essure. These trials, which failed to disclose complaints by trial patients, were presented to the FDA in order to get the agency’s approval for the device.

If you have experienced medical complications or other issues from having the Essure device implanted, or any other medical device issues, contact an experienced Westport personal injury attorney to find out what legal recourse you may have for your pain and loss. For a free initial consultation about your case, call Attorney Richard H. Raphael at 203-226-6168 today.

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